AbbVie and Roche’s Venclexta may have recently hit a stumbling block—but in chronic lymphocytic leukemia, it’s rolling.
Wednesday, the FDA approved a combination of the drug and Roche’s Gazyva for previously untreated patients with CLL or small lymphocytic leukemia (SLL). The regimen, approved speedily under the agency’s Real-Time Oncology Review, represents a chemo-free option for patients.
“Some patients are unable to tolerate chemotherapy regimens due to their underlying health,” Roche’s chief medical officer and head of global product development, Sandra Horning, M.D., said in an October statement after the companies unveiled top-line results.
The approval comes on the back of strong phase 3 data that showed the combo could cut the risk of disease worsening or death by 67% compared with Gazyva plus chlorambucil, a current standard of care. And it’s not the first the partners have collected within the last year; last June, they picked up an FDA approval for a marriage of Venclexta and Roche megablockbuster Rituxan, the predecessor to Gazyva, in previously treated CLL patients.
Both those green lights will help Venclexta toward the $2 billion peak sales mark that analysts have predicted for the drug. But at least for now, multiple myeloma indications won’t. In March, deaths in trials prompted U.S. regulators to halt enrollment of all of Venclexta's myeloma trials; they later revealed that a combination of Venclexta, Takeda proteasome inhibitor Velcade and dexamethasone had doubled patients’ relative risk of death compared with placebo.